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Neoadjuvant (preoperative) concomitant chemoradiotherapy (CRT) is now considered as a standard treatment of locally advanced rectal adenocarcinomas, which correlates better local control and higher sphincter preservation rate. Nimotuzumab, a humanized monoclonal antibody against epidermal growth factor receptor (EGFR) has been reported to improve the therapeutic effect of radiotherapy in some cancers. This study is a clinical phase II trial designed to evaluate the efficacy of the combination of Nimotuzumab administered concurrently with neoadjuvant chemoradiotherapy in patients with locally advanced rectal cancer, and to further investigate its side-effect and toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nimotuzumab plus chemoradiotherapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative irradiation | Radiation | 50.4Gy/28F/5.5w |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pathology complete remission rate | Pathology complete remission rate is the primary outcome measure. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| tumor regression rate | 1 year | |
| local recurrence rate | 5 years | |
| overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310022 | China |
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| ID | Term |
|---|---|
| C501466 | nimotuzumab |
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
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| Nimotuzumab |
| Drug |
400mg/w,0-5w |
|
| Oxaliplatin | Drug | 130mg/m2 d1 |
|
| Capecitabine | Drug | 825mg/m2 bid d1-5/w,1-5w |
|
| 5 years |
| sphincter preservation rate | 3 years |
| Incidence of Adverse Events | up to 1 month after the last cycle |
| D011741 |
| Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |